The $1 Trillion Problem– –

Approximately 18 million Americans currently experience tremor and dementia symptoms indicative of Parkinson’s disease or Dementia with Lewy Bodies(DLB), among others.[1] This is expected to grow to over 30 million Americans by 2050.

The McGovern Institute for Brain Research at MIT predicts that the cost of caring for people with tremor and dementia disorders will expand from $500 billion annually today to more than $1 trillion by 2050 — greater than heart disease and cancer combined.

The use of imaging techniques to manage these diseases became possible with the discovery of the Dopamine Transporter (DaT), a key feature found on the surface of dopamine-producing cells in the brain and responsible for dopamine related brain cell function.

DaT2020TM– –

DaT2020TM is an investigational product candidate, a 123I-labeled tropane molecule, which has been shown in in-vitro studies to bind with high affinity to the dopamine transporter sites in the brain. DaT2020’s high selectivity for the dopamine transporter target ultimately could translate to significantly improved SPECT imaging procedures.

The program consists of 2 trials to be run in parallel.

Phase 3 Pivotal Trial:

DESCRIPTION
This trial intends to recruit about 275 subjects in several sites across the United States. Each subject in the trial will be 40 years of age or older and have upper extremity tremor of 3 years or less in duration. Each subject will be initially diagnosed by a neurologist using current clinical diagnostic tools. They will then be scanned with DaT2020TM. The scans will be read by a panel of 3 independent readers who will reach a diagnosis based solely on the scan results.

PHASE 3 GOAL
Our goal is to determine the relative accuracy of DaT2020TM when compared to traditional clinical diagnosis by a neurologist.

Phase 2B Concordance Trial:

DESCRIPTION
125 subjects in the Phase 3 Trial will be recruited into a separate and distinct Phase 2B trial in which they will be scanned with a competitive imaging agent. TheDaT2020TM scan and the comparator image will be read by a new panel of 3 independent readers to preserve the “blind” on the Phase 3 scans. We will analyze the comparison of the two scans to determine the level of agreement or disagreement between them.

PHASE 2 GOAL
Our goal is to objectively determine whether or not DaT2020TM produces diagnostic results equivalent to or better than the current competitive product.

[1] According to the International Essential Tremor Foundation, the Parkinson’s Disease Foundation and the Alzheimer’s Association